CORE SUMMARY The goal of the Biostatistics and Bioinformatics Core (Core B) is to address the statistical design and analysis needs of the Yale SPORE in Lung Cancer (YSILC) Projects, the other Cores, the Developmental Research Program (DRP), and the Career Development Program (CDP). To accomplish this goal we have assembled a highly interactive team of cancer biostatisticians and bioinformaticians who will work collaboratively with basic, clinical, translational, and population science researchers to advance the frontiers of cancer medicine. The specific aims of the Biostatistics and Bioinformatics Core are: Aim 1: Provide collaboration and consulting in the design and analysis of basic, translational, population and clinical studies for YSILC; Aim 2: Oversee data management and ensure that data collected on all YSILC studies are of high quality and evaluated with statistical rigor; and Aim 3: Design and monitor the statistical conduct of clinical trials, ensuring data are collected and evaluated with statistical rigor and innovation. For Aim1 the Core will address the analytic and informatics questions arising from the SPORE projects. Services provided by the Core will range from planning activities to consulting on specific analytic questions. More specifically, the Core will schedule regular meetings with the YSILC investigators, and maintain an open door policy for any biostatistical and bioinformatics questions. For Aim 2 the Core will work closely with the investigators to analyze clinical trial data, next generation sequencing data, and bioinformatics data mining. For Aim 3 the Core will design and monitor the statistical aspects of clinical trials for safety, efficacy and futility. Since the observed data can have characteristics different from what was hypothesized, the Core will conduct regular interim analyses, dynamically update the power calculations, develop new statistical and bioinformatics methodology as needed, provide timely suggestions to YSILC investigators, and thus play an important role in the projects in the YSILC. Biostatistics and Bioinformatics is also a key partner in the YSILC with representation on their Senior Leadership Team and participation in all core meetings.